Positive Therapy for Autonomic Function & Mood in ICD Patients (PAM-ICD)

• ClinicalTrials.gov Identifier: NCT02088619
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: October 2, 2017
• Sponsor: Medical University of South Carolina
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Medical University of South Carolina

Tracking Information

• First Submitted Date: February 18, 2014
• First Posted Date: March 17, 2014
• Last Update Posted Date: October 2, 2017
• Actual Study Start Date: July 2014
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2014)

• Frequency of arrhythmias between baseline and 3-months [ Time Frame: 3-months ]
  Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 beats per minute [BPM] ) plus arrhythmias detected by the ICD
• Frequency of arrhythmias between 3-months and 9-months [ Time Frame: 9-months ]
  Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 BPM ) plus arrhythmias detected by the ICD

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 13, 2014)

• Frequency of ICD therapies between baseline and 3-months [ Time Frame: 3-months ]
  Obtained from ICD interrogation reports from recording between baseline and 3-months
• Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months [ Time Frame: 3-months ]
  Index of parasympathetic activity; obtained from 24-hour Holter recording
• Frequency of ICD therapies between 3-months and 9-months [ Time Frame: 9-months ]
  Obtained from ICD interrogation reports between 3- and 9-months
• Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months [ Time Frame: 9-months ]
  Index of parasympathetic activity; obtained from 24-hour Holter recording

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 13, 2014)

• Florida Shock Anxiety Scale [ Time Frame: 3 months ]
• Florida Patient Acceptance Scale [ Time Frame: 3-months ]
• Emotions Questionnaire [ Time Frame: 3-months ]
• Center for Epidemiologic Studies - Depression Scale (CES-D) [ Time Frame: 3-months ]
• State Trait Anxiety Inventory (STAI) [ Time Frame: 3-months ]
• Life Orientation Test - Revised (LOT-R) [ Time Frame: 3-months ]
• Positive and Negative Affect Schedule (PANAS) [ Time Frame: 3-months ]
• Satisfaction with Life Scale (SWLS) [ Time Frame: 3-months ]
• Quality of Life Inventory (QOLI) [ Time Frame: 3-months ]
• Short-Form Health Survey-36 (SF-36) [ Time Frame: 3-months ]
• Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 3-months ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Positive Therapy for Autonomic Function & Mood in ICD Patients
• Official Title: Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
• Brief Summary: The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Ventricular Arrhythmia
• Implantable Cardioverter Defibrillator

Intervention

• Behavioral: Quality of Life Therapy (QOLT)
• Behavioral: Heart Healthy Education (HHE)

Study Arms

• Experimental: Quality of Life Therapy (QOLT)
  Positive emotion-focused cognitive behavioral psychotherapy
  Intervention: Behavioral: Quality of Life Therapy (QOLT)
• Active Comparator: Heart Healthy Education (HHE)
  Heart healthy education program
  Intervention: Behavioral: Heart Healthy Education (HHE)

• Publications *: Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 1, 2016): 29
• Original Estimated Enrollment (submitted: March 13, 2014): 60
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
2. Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
3. Able to read and write English
4. Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.

Exclusion Criteria:

1. >5% atrial or ventricular pacing;
2. Sinus node dysfunction;
3. Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
4. Long QT syndrome; and other channelopathies such as Brugada syndrome;
5. Hypertrophic cardiomyopathy;
6. Neurocognitive or cognitive impairments;
7. Severe psychopathology that warrants intensive treatment;
8. Participation in another research trial; and
9. Currently in psychological or psychiatric treatment.
10. Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02088619
• Other Study ID Numbers: Pro00028869; 1R34HL107733-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medical University of South Carolina
• Study Sponsor: Medical University of South Carolina
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Eva R Serber, PhD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: September 2017